Product Development & Regulatory Consulting

Offering decades of strategic development experience, global compliance, and therapeutic experience to ensure your promising therapy isn’t delayed by risk or limited resources.

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Achieving commercial success

Preparing your market application and planning the lifecycle management of your development program are critical to moving your product through early-phase trials and achieving commercial success.

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PREMIER PERSPECTIVE

Product development checklist

A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the development timeline and increase the likelihood of marketing success, especially for small biotech and specialty pharma companies working with limited time and resources.

Taking your product to the next level

Our consultants work with you to design and implement comprehensive plans to enable successful product development from early discovery through IND and post-approval lifecycle management, supporting the regulatory pathway and tactical implementation.

Development Consulting

Global Regulatory Consulting

Commercial

Chemistry, Manufacturing, and Controls

Product Development & Regulatory Consulting Experts

Shari Medendorp, MPH

President, Premier Consulting , ,

Kristi Miller, Ph.D.

Senior Vice President, Regulatory Affairs, Premier Consulting,

Nach Davé, RPh, M.S.

Vice President, Development Strategy, Premier Research,

Robb Lawrence, MBA

Senior Vice President, Commercial Strategy, Premier Consulting,

Related Capabilities

Adding value at every step in the process, we provide expertise in global regulatory consulting, clinical R&D, and technology tools to ensure your trial’s data integrity, process efficiency, and timely analytics and reporting.